The Bad Berka Heart Rhythm Registry (2B2R) is a prospective, single-center observational cohort designed to systematically collect and analyze data of patients undergoing cardiac arrhythmia therapy as well as implantation of cardiac electronic devices (CIEDs) at the Heart Center Bad Berka.
The register aims to evaluate procedural safety, acute and long-term efficacy, and clinical outcomes across a broad spectrum of arrhythmias and interventional strategies, including novel technologies such as pulsed field ablation (PFA) and conduction system pacing. The registry is intended to generate real-world evidence to support clinical decision-making, identify predictors of outcomes, and contribute to quality assurance and innovation in the field of cardiac electrophysiology.
Age ≥18 years
At risk of or with documented cardiac arrhythmia undergoing medical or interventional therapy at the Heart Center Bad Berka
Informed consent obtained
Inability or unwillingness to provide informed consent
Participation in another interventional trial that precludes registry inclusion
Patients with Cardiac Arrhythmias or at Risk for the Development of Cardiac Arrhythmias Undergoing Drug-Therapy or Interventional Procedures at the Heart Center Bad Berka
Cohort
Prospective
Not listed
Acute Treatment Success
1\. Acute Treatment Success Defined as acute symptom control and achievement of predefined procedural endpoints (e.g. AV-nodal modification, elimination of accessory pathway conduction, pulmonary vein isolation, bidirectional block across linear ablation lesions, suppression of ectopic beats, non-inducibility of the clinical arrhythmia, effective occlusion of the left atrial appendage, successful CIED-implantation)
Safety (peri-procedural Complications)
Incidence of major complications (e.g. development of ventricular proarrhythmia, tamponade, stroke, vascular injury, AV-block, phrenic nerve palsy, pneumothorax, hemothorax, lead dislodgment, or death)
Arrhythmia Recurrence
Documented recurrence of the treated arrhythmia after the blanking period (if applicable), using scheduled 24-48h Holter-ECG, 12-lead-ECG, CIEDs, and smart devices (e.g. smart-watch…).
All-cause Rehospitalization
Number of hospitalizations following the index procedure.
Symptom and Quality of Life Improvement
Based on structured follow-up or telephone follow up where applicable.
Device Therapy Outcomes (in patients with CIEDs)- 1.Lead performance -
evaluation of implanted cardiac device leads (pacemaker, ICD, CRT) in terms of electrical integrity, sensing and pacing thresholds, impedance stability.
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